Pulpdent Post Cement is a fluoride releasing, dual cure dental resin cement that contains no Bisphenol A. It is used to permanently cement dental posts, porcelain crowns, inlays, onlays, bridges, veneers, and periodontal splints to tooth structure. Pulpdent Post Cement is also used for bonded amalgam techniques.

Device Description

PULPDENT POST CEMENT is a fluoride releasing, dual cure dental resin cement that contains no Bisphenol A. It is used to permanently cement dental posts, porcelain crowns, inlays, onlays, bridges, veneers and periodontal splints to tooth structure. Pulpdent Post Cement is also used for bonded amalgam techniques.

AI/ML Overview

This submission describes a 510(k) premarket notification for a dental cement (Pulpdent Post Cement), not an AI/ML device. Therefore, the request for information on acceptance criteria, study details, ground truth, and training sets, which are relevant for AI/ML device evaluations, cannot be fulfilled from the provided text.

The document indicates that the Pulpdent Post Cement is claiming substantial equivalence to predicate devices based on design, composition, performance, intended use, safety, and effectiveness. The "Safety and Effectiveness" section explicitly states that the device is substantially equivalent to established predicate products. This means that instead of conducting a new study with acceptance criteria, the manufacturer is asserting that their new device is as safe and effective as devices already on the market, avoiding the need for a de novo marketing authorization or premarket approval.

The submission includes:

Device Name: PULPDENT POST CEMENT
Classification Name: Dental Cement
FDA Product Code: 76 EMA, 21 CFR Part 872.3275
Predicate Devices: Pulpdent ResiLute, Kuraray / J. Morita Panavia F, ESPE Compolute Aplicap, Ivoclar / Vivadent Variolink II
Description and Intended Use: A fluoride-releasing, dual-cure dental resin cement used for permanently cementing dental posts, crowns, inlays, onlays, bridges, veneers, periodontal splints, and for bonded amalgam techniques.
Comparison with Predicate Products: Stated as substantially equivalent in design, composition, performance, intended use, safety, and effectiveness.
Safety and Effectiveness: Relies on the substantial equivalence to predicate products and general usage history of similar dental materials, noting a "high benefit-to-risk ratio" and "no evidence of short-term or long-term risk" based on a NIH Technology Assessment Conference for composites and glass ionomers.

None of the requested information regarding AI/ML device evaluations can be extracted from this 510(k) submission.

Summary

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APR 1 7 2002

PULPDENT CORPORATION

510 k Premarket Notification Pulpdent Post Cement

EXHIBIT 2

-SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA

617-926-6666 Telephone: 617-926-6262 Fax: ken@pulpdent.com

DEVICE: Trade Name: PULPDENT POST CEMENT Classification Name: Dental Cement FDA Product Code: 76 EMA, 21 CFR Part 872.3275

PREDICATE DEVICE:

Pulpdent ResiLute Kuraray / J. Morita Panavia F ESPE Compolute Aplicap lvoclar / Vivadent Variolink II

DESCRIPTION AND INTENDED USE:

COMPARISON WITH PREDICATE PRODUCTS:

PULPDENT POST CEMENT is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.

SAFETY AND EFFECTIVENESS:

PULPDENT POST CEMENT is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above. The predicate products have been found substantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR 872.3275.

According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 20 years indicates a high benefit-torisk ratio... both composites and glass ionomers are relatively trouble-free. There is no evidence of shortterm or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2002

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472

Re: K020481

Trade/Device Name: Pulpdent Post Cement Regulation Number: 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: February 08, 2002 Received: February 13, 2002

Dear Mr. Berk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Kenneth J. Berk

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Tit Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE STATEMENT

KOZO981

510 (k) Number (if known)

PULPDENT POST CEMENT Device Name

Indications for Use:

Please do not write below this line. Continue on another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-
Susan Runge

Over-The-Counter Use

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De : ( ( ( ) Number _

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.